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Eye movement tracking technology developer RightEye got a Form 483 for lapses in its design controls, product handling and complaint procedures, among other deficiencies observed during a June 28 to July 8 FDA inspection of its Bethesda, Md., facility. Read More
Mytrex, a manufacturer of personal emergency response systems, received a Form 483 from the FDA for lack of equipment testing and inadequate recordkeeping, among other lapses observed during an inspection of the company’s South Jordan, Utah, facility. Read More
Wintech Medipro, a manufacturer of surgical and medical face masks in Katy, Texas, has drawn a Form 483 for a host of observations, including inadequate complaint handling, medical device reporting and employee training. Read More
Rockwell Medical received a Form 483 after the FDA observed inadequate corrective and preventive actions (CAPA) and equipment maintenance problems in a July inspection of the company’s Grapevine, Texas, facility. Read More
The FDA issued a Form 483 to RetroFix Screws for inadequate design controls and other deficiencies observed during an inspection of the company’s facility in Salisbury, N.C. Read More
The FDA issued Harmar Mobility a Form 483 for inadequate design validation procedures and other lapses observed at the company’s Lake Winnebago, Mo., facility during a July 11-15 inspection. Read More
The FDA handed Akron Coating & Adhesives a Form 483 for not properly testing or controlling combination drug-device products at its Akron, Ohio, facility. Read More
The FDA has issued a warning letter to Forcemech International in Pearland, Texas, after not getting a response to observations it made during an inspection from March 29 to April 4. Read More
An FDA inspection of Hill Laboratories’ Frazer, Penn., facility found problems with complaint and audit procedures as well as the design of a light therapy unit. Read More
The FDA issued Advanced Facialdontics a Form 483 for lacking a complete design history file and other deficiencies observed during an inspection of the company’s East Islip, N.Y., facility in July. Read More
Ambra Health drew a Form 483 for failing to report a recall to the FDA and properly investigate customer complaints, among other lapses observed during an inspection of its New York City facility. Read More
General Physiotherapy was hit with a Form 483 after an FDA investigator observed product testing and other quality deficiencies at the company’s Earth City, Mo., facility. Read More